This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.
Provide on the floor Quality oversight for the Manufacturing process and staff. Responsibilities include real time decision making regarding deviations and quality impact, review of electronic batch records (EBR) and associated documentation, and support of change over, new product introduction, and validation activities.
Provide coaching, guidance and direction to Manufacturing and Facilities & Engineering staff in regards to compliance and quality systems and acts as the technical specialist in one or more of the following:
Electronic Batch Record (EBR) review and closure
Standard Operating Procedures review and approval in Electronic Document Management Quality (EDMQ)
Quality Assurance Contact on Class 1 Non-conformances and Corrective Action/Preventive Actions (CAPA)
Review and approval of Equipment Use Records (EUR) and Work Orders
Review and approval of validation documents, environmental characterization reports and release of sanitary utilities
May own site quality program procedures
Represent Plant Quality Assurance (PQA) on project teams and Inspection Readiness Walk Throughs
Develop and mentor junior staff
Master's degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience
Bachelor's degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience
Associate's degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience
Previous experience in biopharmaceutical industry
Demonstrated experience in problem solving, decision making and collaboration
Knowledge of Good Manufacturing Practices (GMP) manufacturing and validation practices
System knowledge and training in Quality Management Tracking System (QMTS), SAP, EBR, Maximo and Change Control Management System (CCMS)
Strong organizational skills and ability to multi-task
Ability to follow assignments through to completion and meet timelines
Strong communication skills, (both written and oral), facilitation and presentation skills
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
A little about us:
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